Summary
Overview
Work History
Education
Skills
Accomplishments
Personal Information
Hobbies and Interests
Languages
Timeline
Generic

DNYANESHWARY TALELE

Mumbai

Summary

I have overall 4+ years of experience in the Clinical industry. I am a seasoned SDTM and ADaM programmer in successfully implementing CDISC standards for clinical trial data submissions. Extensively used SAS procedures and functions to produce Tables, listings and figures.

Overview

4
4
years of professional experience

Work History

Statistical Programmer II

Syneos Health
12.2021 - Current
  • Developed and maintained SAS programs to generate statistical reports.
  • Validated and tested SAS programs by comparing results with expected outcomes.
  • Generated tables, listings, as per study requirements using SAS programming language.
  • Utilize SDTM guidelines to build SDTM datasets.
  • Developed and Managed SAS code for mapping clinical data to SDTM data structures in conformance with company's SDTM Implementation Guide, project standards, and the study protocol.
  • Ensure CRF meets the guidelines of the protocol and check for consistency and adequacy.
  • Develop specification and SAS programs to generate ADaM datasets.
  • Validation of domains and datasets using program and Pinnacle 21 validator.
  • Creation of SDTM and ADaM Specification.
  • Creation Trial Design domains.
  • Lead clinical trials for SDTM related activities.
  • Creation of SDRG documents.
  • Preparation of Define.xml.

Statistical Programmer

Tata Consultancy Services
07.2019 - 12.2021
  • Extensive knowledge of clinical trials (I, II, III phases).
  • Having good understanding on CDISC SDTM implementation guidelines.
  • Having a very strong knowledge in the Overall Study flow from study start-up till study submission.
  • Responsible for understanding the study specific protocol and reviewing the eCRF annotations and the Mapping Spec.
  • Responsible for creating CDISC standard SDTM Domains from clinical database.
  • Responsible for Blinding and Unblinding of the study.
  • Created and Reviewed SDTM compliant annotated CRFs (aCRF) as per SDTM Mapping specifications.
  • Validated SDTM datasets using Pinnacle21 before final submission to the sponsor.
  • Worked with SDTM validation team to validate SDTM data to maintain the quality of data.

Education

M.Sc. (Mathematics) -

P.E.S. Modern College of Arts, Commerce And Science, Pune, Savitribai Phule Pune University

B.SC. (Mathematics) -

Dr. Annasaheb G. D. Bendale Mahila Mahavidyalaya, Jalgaon, North Maharashtra University

Skills

  • SAS 94, SAS EG, Pinnacle 21
  • Base SAS, SAS/SQL, SAS/MACROS
  • MS Excel, MS Word, Power point
  • Leadership skills
  • Good Communication Skills
  • Responsible for training and mentoring new joiners

Accomplishments

  • Awarded as a Star performer of the month.
  • Received appreciation from backup TL for outstanding performance, and compliance with all TCS policies in past time.
  • Appreciation from Project leads for achieving milestone for 7 studies on different platform.

Personal Information

  • Blood Group: AB
  • Date of Birth: 02/11/97
  • Gender: Female
  • Nationality: Indian
  • Marital Status: Married

Hobbies and Interests

Cooking, Travelling and Exploring new places

Languages

Marathi, English, Hindi

Timeline

Statistical Programmer II

Syneos Health
12.2021 - Current

Statistical Programmer

Tata Consultancy Services
07.2019 - 12.2021

M.Sc. (Mathematics) -

P.E.S. Modern College of Arts, Commerce And Science, Pune, Savitribai Phule Pune University

B.SC. (Mathematics) -

Dr. Annasaheb G. D. Bendale Mahila Mahavidyalaya, Jalgaon, North Maharashtra University

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